MAUDE Adverse Event Report: Venclose, Inc. Venclose EVSRF Catheter; Venous Catheter

Catalog Number	VC10A256F60
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Codes	Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.Section a through f: the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
On (b)(6) 2026, a patient underwent a radio frequency ablation procedure using the venclose catheter.During the procedure, the catheter temperature fluctuated between one hundred twenty degrees and one hundred thirty degrees celsius, then dropped back to hundred degrees celsius.Blue squiggly lines appeared after each burn.The current status of the patient is unknown.
Event or Problem Description
On (b)(6)2026, a patient underwent a radio frequency ablation procedure using the venclose catheter.During the procedure, the catheter temperature fluctuated between one hundred twenty degrees and one hundred thirty degrees celsius, then dropped back to hundred degrees celsius.Blue squiggly lines appeared after each burn.The current status of the patient is unknown.
Additional Manufacturer Narrative
H11: this supplemental report is submitted to correct an error in the previously submitted reports.The initial mdr and supplemental report 1 listed an incorrect manufacturing location (g1).The correct manufacturing location for this device is viant costa rica, s.A.No new event information is being reported in this supplement.Based on the follow up response, the blue squiggly lines appeared during each activation (burn) without causing any patient injury or burns.Therefore, this complaint indicates no patient harm and is not reportable, with no serious injury (si) downgrade applicable.The file was reassessed for reportability and determined to be no longer reportable.However, since an initial mdr was already submitted, the file will remain classified as a serious injury.G1, g3.Section a through f: the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: Venclose EVSRF Catheter
• Common Device Name: Venous Catheter
• Manufacturer (Section D): Venclose, Inc.; 2750 n. first street; 2nd floor, #221; san jose CA 95131
• Manufacturer (Section G): Viant Costa Rica, S.A.; pq zona franca metropolitana; edificio 2c; barreal de heredia CA 40104 ; CS 40104
• Manufacturer Contact: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 25110825
• Report Number: 3011879048-2026-00046
• Device Sequence Number: 9322331
• Product Code: GEI
• UDI-Device Identifier: 00858254006008
• UDI-Public: (01)00858254006008(17)271017(10)88518373
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K160754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: VC10A256F60
• Device Lot Number: 88518373
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/22/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Supplement Date Received by Manufacturer: 06/23/2026; 09/21/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 07/17/2026; 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown